Dispenser

ABSTRACT

A dispensing apparatus for dispensing a unit dose of a pharmaceutical substance, in particular one for intranasal administration, is disclosed. The unit dose is contained in a cylinder which is moved relative to a piston to expel the contents thereof through a passage in the piston and out of a nozzle opening. The dispensing apparatus includes a case with a base part and a cover.

[0001] The present invention relates to a device for dispensing apharmaceutical substance. In particular, the invention relates to adevice for dispensing a pharmaceutical substance by intranasaladministration.

[0002] European Patent Publication No. EP-A-0546607 in the name of GlaxoGroup Limited discloses a dispenser for manual discharge of a singledose of a flowable substance. The device consists of a casing with anozzle member and shoulders to the sides of the nozzle member. Thenozzle member has a piston extending inwardly from an outlet opening,the piston having at least one discharge channel. A vial of thepharmaceutical substance to be dispensed is mounted on the piston memberwith a stopper arranged across the vial to seal in the substance. Thepiston includes a hollow needle, so that on pressing of the vial ontothe piston member, the stopper is pierced by the needle to allow thesubstance to be expelled through the discharge channel and out of thenozzle opening. The described device is a one-use only device and isintended to be discarded after use.

[0003] International Patent Publication No. WO97/42992 in the name ofGlaxo Wellcome Australia Limited discloses a device for dispensing aunit dose of a pharmaceutical substance. The device includes a bodymember which has a discharge system which can be operated by the user toeffect discharge of the pharmaceutical substance, in particular by meansof a spring loaded air piston which injects air into a container of thesubstance to discharge it. A number of nozzle assemblies are provided,each nozzle assembly including a container of a unit dose of thepharmaceutical substance. A single nozzle assembly is mounted on thebody member and in one embodiment a driving spring for the air piston isloaded with spring energy by the action of mounting the nozzle assemblyon the body. After the spring is released, and the substance thusdischarged, the nozzle assembly is discarded and a fresh nozzle assemblycan be mounted on the body as required.

[0004] U.S. patent Publication No. U.S. Pat. No. 5,137,516 again in thename of Glaxo Group Limited describes a device for administering a doseof a pharmaceutical substance, in particular by self-injection by theuser. The device holds a syringe of the pharmaceutical substance and thesyringe is pressed against the user's skin by a spring force, the springforce being released by relative movement of cooperating sleeves of thedevice and by pressure on a button on one end of the device. The springcan be placed into a ready-to-use state by loading of the syringe ontothe device. The device may be provided in a carry case, along with asmall number of spare syringes.

[0005] There remains a need for a pharmaceutical dispensing device whichis easy and convenient to use.

[0006] According to the invention there is provided a device fordispensing a pharmaceutical substance comprising:

[0007] a base member and a cover member closeable thereon;

[0008] a dispensing member which is movable between a first position onthe base member under the closed cover member and a second positionprotruding from the base member after opening and reclosing of the covermember;

[0009] a container of the pharmaceutical substance to be dispensed;

[0010] an actuating member for discharging the pharmaceutical substancefrom the container and through the dispensing member;

[0011] wherein in the second position of the dispensing member thecontainer is in registration with the actuating member so that therelease member can cause dispensing of the pharmaceutical substancethrough the dispensing member.

[0012] Preferably, the dispensing member includes the container and thedispensing member is removable from the base member for disposal afteruse.

[0013] The dispensing member is preferably pivotable relative tithe basebetween the first and second position.

[0014] The dispensing member can have a protective cap which has lockingwings to hold it on the dispensing member, the locking wings beingretracted upon mounting of the dispensing member on the base.

[0015] The base member preferably has an edge surface which preventsregistration of the dispensing member with the actuating member untilremoval of the protective cap.

[0016] The actuating member has a primed condition and an unprimedcondition, and the primed condition can be achieved by sliding movementof a carriage on the base member.

[0017] The cover member advantageously cooperates with the carriage suchthat after dispensing, opening of the cover member slides back thecarriage to its initial position.

[0018] A push button on the base or cover member can move the releasemember, inclined surfaces on the release member then moving catches onthe base member which hold the actuating member.

[0019] A preferred embodiment of the invention is described in moredetail below, by example only, with reference to the accompanyingdrawings.

[0020]FIG. 1 is a perspective view of a device for dispensing apharmaceutical substance in accordance with an embodiment of theinvention, in a closed condition;

[0021]FIG. 2 is a perspective view of the device of FIG. 1 in an opencondition;

[0022]FIG. 3 is an exploded perspective view of the device of FIGS. 1and 2, but omitting the unit which contains the pharmaceutical substanceto be dispensed;

[0023]FIG. 3a is a perspective view of a part of FIG. 3, but at a largerscale;

[0024]FIGS. 4a and 4 b are perspective views of the unit which containsthe pharmaceutical substance, FIG. 4a being a partly exploded view;

[0025]FIGS. 5a and 5 b are vertical and horizontal sectional views ofthe device, showing the unit containing the pharmaceutical substance inits inner position;

[0026]FIGS. 6a and 6 b are sectional views similar to those of FIGS. 5aand 5 b, but showing the unit containing the pharmaceutical substance inits outer position, ready-to-use;

[0027]FIGS. 7a and 7 b are similar sectional views, showing the devicein a primed condition;

[0028]FIGS. 8a and 8 b are similar sectional views showing the device ina used condition, with the pharmaceutical substance having beendispensed;

[0029]FIGS. 9a and 9 b are perspective views from above and from belowshowing in detail the operation of the release mechanism of the device;and

[0030]FIGS. 10a to 10 f are detail sectional views showing the movementof parts of the device as the base and cover are moved relative to oneanother.

[0031] The perspective view of FIG. 1 shows a device 1 for dispensing apharmaceutical substance, the device being in the form of a carry caseof a generally parallelepiped shape, the edges, ends and upper and lowersurfaces of the parallelepiped shape being rounded.

[0032] The carry case includes a base member 2 and a cover member 3,these members being hingedly connected to one another at the lower endof the device as seen in FIG. 1. At the upper end of the device as seenin FIG. 1, where the base 2 and cover 3 move apart from each other, anopening 4 is provided in the end of the base, this opening 4 beingclosed by a lid 5 which is mounted on the cover 3.

[0033] Lifting of the cover 3 from the base 2, and thus opening of thedevice, is achieved by squeezing together the sides of the cover 3.

[0034] The open condition of the device is shown in the perspective viewof FIG. 2. In this Figure it can be seen that the cover 3 is pivotedaway from the base 2. A unit 6 which contains the pharmaceuticalsubstance to be dispensed is mounted on a support 7 which in turn ispivotally mounted on the base 2. In this embodiment, where thepharmaceutical substance is intended for nasal administration, the unit6 is of a generally cylindrical shape with dimensions appropriate forinsertion into the user's nasal cavity, after removal of a protectivecover.

[0035] In view of its shape and function, the unit 6 which contains thepharmaceutical substance is referred to in the following description asa nozzle unit.

[0036] On the cover 3 are arranged spare nozzle units 8, each of thesebeing identical to the nozzle unit 6 mounted on the base 2 by means ofthe support 7.

[0037] The lid 5 which closes the end opening 4 of the base 2 is seen atthe bottom of FIG. 2. Lid 5 is arranged on the cover 3 by means of apivotal mounting 9.

[0038] The means by which the cover is opened and closed, relative tothe base, are visible in the perspective view of FIG. 2. Curved portions10 extend from the sides of the cover 3 and locate in correspondinglyshaped recesses 11 in the sides of the base 2. A catch 12 on the curvedportion 10 locates in a catch recess 1 on the inside of the cover,immediately adjacent the recess 13. Upon closing of the cover on thebase, due to the inherent resilience of the material from which thecover is formed, the catch 12 locates in the catch recess 11. Opening ofthe cover 3 is achieved by squeezing together the sides of the cover, atthe curved portions 10, thus releasing the catch 12. The arrangement ofthe catch and catch recess is of course present on both sides of thedevice.

[0039] The construction of the base and the cover, and the componentparts thereof, are clearly shown in the exploded perspective view ofFIG. 3. This Figure does not, however, show the nozzle unit 6 or thespare nozzle unite 8. In FIG. 3, the cover 3 is shown separated andabove the base 2. The pivoting support unit 7 is seen to the left ofbase 2. Carriage 14 is also seen above the base 2, this carriagenormally being arranged on base 2 for sliding movement between a first,rearward position and a second, advanced position. Piston rod 15 is alsonormally mounted on the base, and this piston rod 15 can be driven bythe force of piston spring 16 to urge the pharmaceutical substance fromthe nozzle unit 6, upon actuation of the dispensing device.

[0040] The piston rod 15 is maintained in a non-dispensing position byresilient arms 17 on the inside of the base 2. Actuation of the device,and thus release of the piston rod 15, occurs by means of pressure on abutton 18 located in the base 2, button 18 cooperating with a shuttle19. Inclined surfaces 20 on the button 18 act on inclined surfaces 21 ofthe shuttle 19 to move the shuttle 19 along the base, this movementopening the arms 17 to release the piston rod 15, as will be describedin more detail below. The shuttle 19 moves against the action of shuttlespring 22.

[0041] The shuttle 19 is initially held against movement along the baseby a first safety catch 23 and a second safety catch 24. The purposes ofthe safety catch catches are to ensure that the dispensing device isproperly and safely used. The full purpose of these safety features willbe described below.

[0042] The carriage 14 includes a blocking arm 25, which blocks forwardmovement of the carriage when a nozzle unit is mounted on the support 7and pivoted inside the device 1 (i.e. in the position seen in FIG. 2).The carriage 14 also includes piston rod housing 26 through which thepiston rod 15 extends. At each side of the carriage 14 is a catch arm 27at the forward end of which there is a hook catch 28. The catches 28engage over shoulders 29 on the base 2, when the carriage 14 is mountedin a rearward position on the base 2.

[0043] On each side of the carriage 14, adjacent the catch arms 27 thereis arranged a cam track 30. A pin 31 at each inner side of the pivotingend of cover 3 moves around the cam track 30 in a manner to be describedbelow. The pivoting end of the cover 3 includes apertures 32 whichlocate over pivot lugs 33 on the base 2, to allow pivotal movement ofthe cover relative to the base 2.

[0044] Pivoting lugs 34 are provided on the support 7, these lugs 34locating in pivot apertures 35 at the forward end of the base 2. Thus,the support 7 can pivot about the base, between a position facinginwardly of the base and a position facing outwardly of the base. In theouter position the support 7 locates in the opening 4 of the base.

[0045] Cover spring 36 is fitted on the cover, to urge the lid 5 into aposition closing the opening 4 when the support 7 is folded inside thebase. When the support 7 is folded out of the base, obviously the lid 5cannot cover the opening 4 and in, this situation, when the cover isclosed on the base, the lid 5 is folded back inside the cover, againstthe action of cover spring 36.

[0046] A plug 37 is provided to close the end of the passage through thepiston housing 26 of the carriage 14. The end of the passage is notvisible in FIG. 3, but it can be explained here that the piston rod 15and piston spring 16 are mounted in the carriage 14 by insertion throughthe outer end of the carriage, the opening in the carriage then beingclosed by the plug 37.

[0047] An inner cover plate 38 is provided between the base 2 and thecover 3. The cover plate 38 is mounted on the base to conceal theoperating parts of the actuating mechanism, in particular the shuttle19, spring arms 17 and inner surfaces of the button 18.

[0048] The support 7 is shown in more detail in the enlarged perspectiveview of FIG. 3a. The support 7 is shaped so as to snugly receive thenozzle unit 6. Correct mounting of the nozzle unit 6 is ensured by meansof a groove 75 which curves around the inside of the support.Immediately adjacent the groove 75 are opposing inclined surfaces 76which approach each other as they extend into the support. The purposeof groove 75 and surfaces 76 will be explained shortly.

[0049]FIGS. 4a and 4 b show the nozzle unit 6 which in FIG. 2 is shownmounted on the pivoting support 7. The nozzle unit 6 includes a cap 40,a nozzle member 41 and a vial holder 43 which holds a vial of thepharmaceutical substance to be dispensed (the vial not being visible inthis Figure). At each side of the cap 40 are cap wings 44 and at the endof each wing there is a protruding part 45 which forms a cap wing catch.The nozzle member 41 has a skirt 46 extending laterally therefrom, theskirt having skirt legs 47 and skirt openings 48. The cap wings 44 areresilient and upon location of the cap 40 over the nozzle member 41 thecap wings 44 locate in the skirt openings 48, with the cap wing catches45 clipping under the skirt to prevent removal of the cap 40 from thenozzle member 41.

[0050] The skirt legs 47 include, on their inner surfaces, acircumferential groove 49. At the forward end of the nozzle member 41there is a nozzle opening 50, through which the pharmaceutical substanceis dispensed after the nozzle member is inserted in the user's nasalcavity.

[0051] The skirt 46 has a rounded shape on one side which matches thecurved shape of the groove 75 of the support 7. This matching of shapeensures that the nozzle unit can only be inserted into the support inone predetermined orientation. Upon insertion, the skirt 46 fits in thegroove 75 and the cap wings 44 will be forced along the surfaces 76which will tend to draw the cap wings 44 closer together.

[0052] The vial holder 43 is of a generally cylindrical shape andlocates within the nozzle member 41. A circumferential rim 51 at thebase of the vial holder 43 locates in the circumferential groove 49 ofthe skirt legs 47 in order that the vial holder can be securely heldwithin the nozzle member 41. The skirt legs have a degree of resiliencyso that the vial holder can be pushed further within the nozzle member41 by an appropriate force.

[0053] It can be mentioned at this point that the inner construction andthe working of the nozzle member is, in this embodiment, exactly asdescribed in European patent application number EP-A-0546607. Thus theway in which the pharmaceutical substance is held within the nozzlemember, and the way in which it is dispensed, need not be described indetail here. It can, however, be noted that the vial holder 43 in thepresent device is shorter than the equivalent member in EP-A-0546607. Inthe present case, it can be seen that the vial holder does not extendbeyond the ends of the skirt legs 47, so that accidental pressure on thevial holder 43, when the nozzle units are handled by the user, isavoided, the skirt legs 47 surrounding and protecting the end of thevial holder 43.

[0054] The vertical cross-sectional view of FIG. 5a shows the device ina closed condition, with the cover 3 closed onto the base 2, the lid 5closing the opening 4. The support 7 with a nozzle unit 6,mountedthereon is folded inside the device. As clearly seen in this Figure, theend of the blocking arm 25 of the carriage 14 is adjacent the end of thepivot unit 6, thus blocking movement of the carriage 14 along the base2. Piston rod 15 is seen mounted within the piston housing 26 of thecarriage, the end of the carriage housing 26 being closed by the plug37.

[0055] One side of the piston housing 26 has an open portion 54 intowhich one end of the shuttle 19 can move, when the carriage is advanced.FIG. 5a shows the shuttle catch 24 of the shuttle 19 located in a catchrecess 55 in the base 2, the holding of the catch 24 in the recess beingagainst the force of the inherent resiliency of the end portion of theshuttle 19. Accordingly, when the carriage is in such a position thatthe open portion 54 of the piston support 26 is next to the shuttlecatch 24, that catch can move out of the catch recess 55.

[0056] At the end of the shuttle 19 nearest to the opening 4 a lip 56 ofthe shuttle catch 23 locates over a shoulder 57 on the base 2. Uponrotating of the support 7 together with the nozzle unit 6 out of thecase, and upon removal of the cap 40, the shuttle catch 23 is presseddown so lifting the lip 57 away from the shoulder 56. This is describedin more detail below with reference to FIG. 6a.

[0057] In the sectional view of FIG. 5a are also seen the internalcomponent parts of the nozzle unit 6. As described in more detail inEP-A-0546607 there is a piston member 71 in which is mounted a hollowneedle 72. Held within the vial holder 43 is a vial 73 closed by arubber stopper 74. The hollow needle 72 is in alignment with the nozzleopening 50. Upon depression of the vial holder 43, the needle 72 piercesthe rubber stopper 74 and the stopper is pushed along the vial 73 by thepiston member 71, thus expelling all of the contents through the needleand thus through the nozzle opening.

[0058] The horizontal sectional view of FIG. 5b shows more clearly themounting of the carriage 14 and piston member 15 on the base 2. Asalready mentioned, the carriage 14 can slide along the base from therearward position shown in FIG. 5b to a forward position. In therearward position the hook catches 28 of the arms 27 of the carriage 14locate over the shoulders 29 of the base. It will be noted that similarshoulders 68 are provided on the inside of the cover 3, in a moreforward position relative to the carriage, and when the cover is closedon the base of the shoulders 68 provide an advanced position for thecatches 28 (these shoulders 68 of the cover can also be seen in FIG. 2).

[0059] The piston member 15 is mounted on the carriage 14 through pistonhousing 26. At the rearward end of the piston there are two annularshoulders 61 and 62. Piston spring 16 is located against the shoulder61, the other end of the spring being located against the inner end ofthe plug 37 which is force fitted into the rearward end of the carriage.The other, more forward shoulder 62 abuts an annular lip 63 of thecarriage housing 26, thus preventing the piston member from movingfurther out of the housing 26.

[0060]FIG. 5b also shows in more detail the blocking of the piston rod15 by the resilient arms 17 which are mounted on the base 2. At theirrearward ends, the spring arms 17 have lugs 64 which engage against anannular shoulder 65 of the piston rod 15. Rounded portions 66 on theinside of the spring leg 17 rest against inclined surfaces 67 of theshuttle 19. The cooperation of the shuttle 19 and spring arms 17 will bedescribed in more detail below, but it is evident from FIG. 5b that thepiston rod 15 cannot move to a more forward position until such time asthe resilient arms 17 are opened.

[0061] The sectional views of FIGS. 6a and 6 b are similar to those ofFIGS. 5a and 5 b, but these Figures show the device in a ready-to-usestate. The nozzle member 41 is positioned outside of the device so thatit can be inserted into the user's nasal cavity. To arrive at thisposition, the cover 3 must be opened and the nozzle unit 6 pivotedoutwardly on the support 7. After pivoting out of the nozzle unit, thecap 40 is removed and the cover 3 is closed again. The closing action ofthe cover forces the lid 5 against the support 7 and the lid 5 ispivoted inside the cover 3, against the action of the lid spring 36. Inthe outward position of the nozzle member 41 the outer end of the vialholder 43 is immediately adjacent the forward end of the piston member15. The nozzle member is firmly held in place on the support 7 by theedges of the opening 4 of the base.

[0062] Upon previous mounting of the nozzle unit on the support 7 theinclined surfaces 76 on the inside of the support 7 have acted againstthe cap wings 44, thus moving the cap wing catches 45 into a position atwhich they can move through the skirt openings 48 of the nozzle member41. In other words, correct mounting of the nozzle unit 6 on the support7 automatically releases the locking engagement of the cap 40 on thenozzle member 41. Thus, the cap 40 can easily be removed from the nozzleunit 6 when the nozzle unit is pivoted away from the base. Until suchtime as the cap 40 is removed, the nozzle member 41 cannot be moved tothe position shown in FIG. 6a, in alignment with the piston rod 15,because the cap 40 is wider than the nozzle member 41 and would abut theedge of the opening 4. Equally, until the cap 40 is removed the cover 3cannot close on the base 2, as the nozzle unit would be blocking thefinal engagement of the cover on the base.

[0063] It will be seen from FIG. 6a that when the nozzle member 41 iscorrectly positioned, pivoted outwardly of the base, then the shuttlecatch 23 locates in the gaps between the skirt arms 47 of the nozzlemember 41, thus allowing the vial holder 43 to press the catch 23. Theshuttle catch 23 is arranged at the end of the shuttle 19 on a “livinghinge” and a force on the inclined surface of the shuttle catch 23 actsto pivot the lip 56 off the shoulder 57 of the base 2. It can be notedat this stage that if an already used nozzle member were mounted, thenthe vial holder 43 would be at an advanced position within the nozzlemember 41 and could not, therefore, contact the shuttle catch 23 torelease it.

[0064] To bring the device shown in FIGS. 6a and 6 b into an actuationcondition, it is necessary to advance the carriage 14 along the base 2.This is done by the user pushing the carriage 14 into the device, forexample by means of thumb pressure on the surface of the plug 37.

[0065] The advanced position of the carriage 4 is shown in FIGS. 7a and7 b. From FIG. 7b, it can be appreciated that carriage 14 is advanced toa forward position in which the carriage hooks 28 engage over theshoulders 68 on the inside of the cover 3. The carriage arms 27 have asufficient degree of resiliency to allow the hooks 28 to pass theshoulders 68, before snapping outwardly to engage over the shoulders 68.

[0066] As the piston member 15 remains blocked by the resilient arms 17on the base 2, on the advancement of the carriage 14, the piston housing26 moves along the piston member 15 and the piston spring 16 iscompressed between annular shoulder 61 of the piston member 15 and theinside of the plug 37. In the advanced position of the carriage 14, theopen portion 54 of the piston housing 26 registers with the catch 24 ofthe shuttle 19, thus allowing the catch 24 to disengage from the catchhole 55 in the base 2.

[0067] In the condition seen in FIGS. 7a and 7 b, both safety catches 23and 24 of the shuttle 19 are released from the base 2, leaving theshuttle 19 in a condition in which it is able to move along the base 2,against the action of shuttle spring 22.

[0068]FIGS. 8a and 8 b show the condition of the device wherein thebutton 18 has been depressed, the resilient arms 17 opened and thus thepiston rod 15 released. The cooperation of the button 18 with theshuttle 19 and the resilient arms 17 is described in detail below withreference to FIGS. 9a and 9 b.

[0069] Upon opening of the resilient arms 17, the lugs 64 move away fromthe shoulder 65 of the piston rod is. As soon as the resilient arms 17are clear of the piston rod 15, the force of the piston spring 16 urgesthe piston rod 15 forwardly, immediately pushing the vial holder 43 intothe nozzle member 41. In the same way in which the pharmaceuticalsubstance is dispensed in prior application EP-A-0546607, movement ofthe vial holder 43 within the nozzle member 41 in the present devicecauses the contained pharmaceutical substance to be sprayed out of thenozzle opening 50 into the user's nasal cavity.

[0070] Of course, for delivery of the pharmaceutical substance, the userplaces the device in such a position that the nozzle member 41 is in oneof the nasal cavities, the device being held in the hand with the thumbover the button 18.

[0071] Upon release of the button 18 (i.e. when the button moves to theleft in FIG. 8a) the shuttle spring 22 will move the shuttle 19 in aforward direction so that the shuttle catch 23 is again engaged with thebase 2. It is seen from FIG. 8a that with the vial holder 43 advancedwithin the nozzle member 41 the shuttle catch 23 is allowed to assumeits position engaged behind the shoulder 57 of base 2.

[0072] As indicated above, FIGS. 9a and 9 b show the cooperation betweenthe button 18, the shuttle 19 and the arms 17 of the base 2. Theperspective views of FIGS. 9a and 9 b are from opposite sides, so thatboth top and bottom surfaces of the relevant parts can be seen.

[0073] Button 18 is of a generally circular configuration and is clippedinto a correspondingly shaped aperture in base 2. On the inside surfaceof the button 18 there are two sets of two inclined surfaces 20 whichare for sliding engagement with correspondingly inclined surfaces 21 onthe shuttle 19. The surfaces 21 are formed on integrally moulded blocks80, 81 along the length of the shuttle 19. The block 81 nearest toshuttle catch 24 includes the lateral inclined surfaces 67 which arebevelled outwardly, away from the shuttle catch 24 end.

[0074] Between this block 81 and the shuttle catch 24 is formed arectangular opening 83 including a pin 84 for location of the shuttlespring 22. On assembly of the shuttle 19 to the base 21 the rectangular83 opening fits over an internal lip 85 of the base 2 (see. FIG. 5a forexample), with the shuttle spring 22 abutting against the lip 85.

[0075] Upon movement of the button upwardly as seen in FIG. 9 a, ordownwardly as seen in FIG. 9b, the inclined surfaces 20 of the buttonmove against the correspondingly inclined surfaces 21 of the shuttle 19,thus forcing the shuttle to the right in FIG. 9a, i.e. rearwardly in thedevice. This movement in turn pushes the lateral inclined surfaces ofthe block of the shuttle 19 along the rounded portions 66 of theresilient arms 17, forcing the arms 17 to open and releasing the lugs 64from the shoulder 65 of the piston arm is.

[0076]FIGS. 9a and 9 b clearly show the safety catch 23, including theliving hinge 86 connecting the catch to the shuttle 19.

[0077] After actuation of the device, the used nozzle member 41 willneed to be disposed of. To remove the nozzle member, the cover 3 isopened, the support 7 pivoted back inside the base 2 and the used nozzlemember 41 removed for safe disposal.

[0078]FIGS. 10a to 10 e show how the opening of the cover 3 retracts thecarriage 14 to its rearward position. As briefly mentioned in relationto FIG. 3, a pin 31 on each side of the pivoting end of the cover 3cooperates with a cam track 30 on the sides of the carriage 14. At thebase side of the track, there is a straight portion 90 which is parallelto the direction of movement of the carriage 14 along the base 2. At theforward end of this straight portion there is an arcuate portion 91extending back around approximately 180°. From the rearward end of thestraight portion a slightly curved portion 92 extends to intersect thearcuate portion 91 approximately ¾ of the way along its length from theforward end of the straight portion 90.

[0079]FIG. 10a shows the cover closed 3 on the base 2, with the carriage14 in its normal, rearward position. Here the pin 31 is located at theforward end of the straight portion 90 of the track 30. It is clear thatupon opening and closing of the cover 3, the pivotal movement of thecover will move the pin 31 along the arcuate portion 91. With 180°opening of the cover 3, the pin 31 will of course arrive at the oppositeend of the arcuate track 91.

[0080]FIG. 10b shows the carriage 4 in its advanced position, i.e. in aposition shown in FIGS. 7a and 7 b. With the forward movement of thecarriage 14 along the base 2, the pin 31 moves relative to the carriage14 such that it is located at the rearward end of the straight portion90 of the track. After actuation of the device and opening of the cover3, it is seen in FIG. 10c that the pin is forced along the inclinedportion 92 which acts as a cam surface. Thus, pivoting of the cover 3forces the pin to retract the carriage 14.

[0081] The retracted position of the carriage is seen in FIG. 10 d. Forcompleteness, it is noted at this point that opening of the coverdisengages the shoulders 68 of the cover from the hooks 28 of thecarriage, freeing the carriage to move back to its initial position.Upon full retraction of the carriage 14 the pin 31 is able to move tothe end of the arcuate portion 91 of the track, should full 180° openingof the cover be desired by the user. This condition is seen in FIG. 10e.

[0082] Whether the cover 3 is moved back to the closed position from thestate seen in FIG. 10d or the state seen in FIG. 10e, it will beunderstood that upon pivoting of the cover 3 relative to the base 2 thepin 31 will travel back around the arcuate portion 91 of the cam track30 to the position shown in FIG. 10a. In this condition, the cover 3 isclosed and the carriage 14 is again in its rearward position.

[0083] Having described the construction of the device for administeringa pharmaceutical substance in accordance with this embodiment of theinvention, the way the device is intended to be used will now bedescribed (though many of the aspects of the operation of the devicewill already have been understood from the above description of thedevice and the interaction of the different parts thereof).

[0084] In the normal situation, the user will start with a closeddevice, with an unused nozzle unit 6 mounted on the support 7 and foldedonto the base 2 with the cover 3 folded down thereover. In other words,in the normal start condition the device will be in the condition seen,in FIGS. 1 and 5.

[0085] If it is assumed that the pharmaceutical substance contained inthe nozzle unit is Sumatriptan then the device will be used for thealleviation of the symptoms of a migraine. On sensing the onset of amigraine attack, the user will lift the cover 3 of the device and foldout the nozzle unit 6. Previous mounting of the nozzle unit on thesupport 7 will have disengaged the catches on the cap 40 of the nozzleunit 6. Thus, the user can easily remove the cap 40 so that the nozzlemember is ready for location in the nasal cavity. After removal of thecap 40, the cover 3 is closed back onto the base 2. If the support, 7has not already be pivoted out to its full extent, the closure of thecover 3 on the base 2 will complete the movement of the support 7, andthus the nozzle member 41, so that the nozzle member 41 is correctlyaligned with the piston rod 15. This condition is seen in FIGS. 6a and 6b.

[0086] As already mentioned above, pivoting of the nozzle unit out toits full extent releases the forward catch 23 of the shuttle 19. In thisposition, the device is ready to be brought into an actuation conditionby the user. To achieve this, and thus to cock the spring 16 whichdrives the piston rod 15, the user presses the carriage 14 into thedevice, thus forcing the carriage 14 to slide along the base in adirection towards the nozzle unit. As the piston rod 15 is blocked bythe spring arms 17, the piston housing 26 of the carriage 14 slidesrelative to the piston rod 15, thus compressing the piston spring 16. Inthe advanced position of the carriage 14, the catches 28 on the carriagearms 27 locate over the forward shoulders 68 of the cover 3. With thecarriage in the advanced position, the rearward catch 24 of the shuttle19 has disengaged from the base 2. This position of the carriage is seenmost clearly in FIG. 7b.

[0087] The device is now ready to be operated by the user in order todeliver a predetermined dose of the pharmaceutical substance. The deviceis held in the user's hand, with the nozzle member correctly located inthe nasal cavity and the button 18 is depressed. Depression of thebutton 18 forces the shuttle 19 to slide in a rearward direction, thelateral inclined surfaces 67 of the shuttle 19 opening the arms 17 ofthe base. With the arms 17 separated, the piston rod 15 is released sothat under the force of the spring 16 it drives the vial holder 43 intothe nozzle member 41. Thus, the pharmaceutical substance is delivered tothe user, in the same manner as described in prior applicationEP-A-0546607.

[0088] With the spring 16 having a predetermined resilient force, thepiston rod 15 will be driven with a predetermined and relativelyconstant force, so that a very reliable expulsion of the substance outof the nozzle opening 50 will be achieved. The condition of the devicewith the piston rod released and the substance dispensed is shown inFIGS. 8a and 8 b.

[0089] At this stage the actions of any individual user cannot bepredicted, in that if someone is suffering from a severe migraine attackthey may at this point simply put the device down and only deal with itwhen the attack is over, or at least the symptoms have been greatlyalleviated. However, after actuation, the user will ideally open thecover, fold in the used nozzle member 41 and remove that nozzle memberfor disposal. The cover can of course be closed again at this point, butit is preferable for a replacement nozzle unit 6 to be located in thesupport 7, so that the device will be immediately ready for use at alater date. A spare nozzle unit will be present on the inside of thecover 3 and that spare unit can itself be replaced by another unit.

[0090] As discussed in particular in relation to FIGS. 10a to 10 e, theopening of the cover 3, after administration of the pharmaceuticalsubstance, automatically brings the carriage 14 back to its rearwardposition. Thus, on mounting a replacement nozzle unit and again closingthe cover, the device is again in a ready-to-use condition, as seen inFIGS. 5a and 5 b. It is thus understood that the device is easy to useand can be operated in a reliable and straightforward fashion to quicklyand efficiently dispense a dose of pharmaceutical substance, as the needarises.

[0091] It will also be appreciated that the device includes severalsecurity features to ensure that the device is operated in the intendedfashion. In particular, the following features are included.

[0092] 1. The cover joins with the base by means of a child proofclosure. Only by applying inward pressure to the sides of the cover atthe appropriate point can the device be opened.

[0093] 2. The cap of the nozzle unit can only easily be removed uponmounting of the nozzle unit on the support. Thus, the cap protects thenozzle itself from contamination, prior to use (the pharmaceuticalitself, inside the nozzle member, is sealed inside the vial, until suchtime as the stopper is punctured by the needle). The cap also acts as atamper evident feature, so that the user can immediately see if a nozzlemember has already been used. In other words, the user will only try andadminister the pharmaceutical substance from a nozzle unit which has acap correctly in place.

[0094] 3. The cap cannot be removed from the nozzle unit until thesupport is pivoted to the outward position. Thus, the cap cannot beinadvertently removed after initial mounting of the nozzle unit on thesupport with the support still folded inwardly of the base.

[0095] 4. The piston spring cannot be cocked until the device is in aready-to-use condition. In particular, until the nozzle unit is pivotedout, the carriage is blocked by the nozzle unit mounted on the support.Similarly, there is no possibility of cocking the spring when the caseis open as the carriage cannot be engaged in a forward position untilthe shoulders 68 of the cover are adjacent the base.

[0096] 5. The cover cannot be closed onto base until the cap is removedfrom the nozzle unit which has already been pivoted out from the base.Thus, there is no possibility of the user trying to administer thepharmaceutical substance without first removing the cap from the nozzlemember.

[0097] 6. Only with the cap removed from the nozzle unit can the nozzlemember be fully pivoted out from the base and only in the fully pivotedposition will the vial holder release the forward catch of the shuttle.Thus, the shuttle is locked against movement until a nozzle unit withthe cap removed is pivoted out.

[0098] 7. If the user tries to activate the device with an already usednozzle member, then the vial holder will be in such a forward positionthat it does not release the catch of the shuttle. Thus, the user cannotreuse a nozzle member. Similarly, if no nozzle member at all is presentthe shuttle catch remains locked against the base.

[0099] 8. The rearward shuttle catch remains locked against the baseuntil such time as the carriage is in its forward position. Thisprevents the piston rod from being released by pressure on the buttonuntil such time as the piston spring is properly compressed. Thus,reliable dispensing of the pharmaceutical substance within the nozzlemember is ensured.

[0100] 9. The nozzle units themselves are protected against accidentalactuation by virtue of the fact that the skirt legs of the nozzle membersurround the vial holder, so that upon handling of the nozzle unit thevial holder is not accidentally pushed into the nozzle member by theuser's fingers or thumb.

[0101] The component parts of the device described above are mouldedfrom a suitable plastics material. For example, the base, cover andsupport can be made of ABS (Acrylonitrile Butadiene Styrene) orpolycarbonate (PC). The carriage, button and plug can similarly be madeof PC, while the piston and shuttle might be made of polyoxymethylene(POM). The springs are made of steel.

1. A device for dispensing a pharmaceutical substance comprising: a basemember and a cover member closeable thereon; a dispensing member whichis movable between a first position on the base member under the closedcover member and a second position protruding from the base member afteropening and reclosing of the cover member; a container of thepharmaceutical substance to be dispensed; an actuating member fordischarging the pharmaceutical substance from the container and throughthe dispensing member; wherein in the second position of the dispensingmember the container is in registration with the actuating member sothat the actuating member can cause dispensing of the pharmaceuticalsubstance through the dispensing member.
 2. A device according to claim1, wherein the dispensing member includes the container.
 3. A deviceaccording to claim 1 or 2, wherein the dispensing member is removablefrom the base member for disposal after use.
 4. A device according toclaim 3, wherein two or more spare dispensing members are mountable onthe base or cover member.
 5. A device according to any preceding claim,wherein the dispensing member is pivotable relative to the base memberbetween the first and second positions.
 6. A device according to claim5, wherein the dispensing member is mounted on a support which ispivotally connected to the base member.
 7. A device according to claim6, wherein the dispensing member has a protective cap which has lockingwings to hold it on the dispensing member, the pivotal support havingsurfaces which retract the locking wings upon mounting of the dispensingmember on the support.
 8. A device according to claim 6 or 7, whereinthe dispensing member is slidable onto and off the pivotal support.
 9. Adevice according to claim 7 or to claim 8 when appended to claim 7,wherein the base member has an edge surface which prevents registrationof the dispensing member with the actuating member until removal of theprotective cap.
 10. A device according to any preceding claim furthercomprising a latch for latching the actuating member and a releasemember for releasing the actuating member from the latch.
 11. A deviceaccording to claim 10, wherein the release member has at least a firstsafety catch which holds it in position on the base member, the firstsafety catch being released by movement of the dispensing member to thesecond position.
 12. A device according to any preceding claim, whereinthe actuating member has a primed condition and an unprimed condition,the primed condition being achieved by sliding movement of a carriage onthe base member.
 13. A device according to claim 12 when appended toclaim 10 or 11, wherein sliding of the carriage compresses a springwhich is releasable by the release member to actuate the actuatingmember.
 14. A device according to claim 12 or 13 when appended to claim11, wherein the release member has a second safety catch which holds itin position on the base member, the second safety catch being releasedupon sliding movement of the carriage.
 15. A device according to claim12, 13 or 14, wherein the cover member cooperates with the carriage suchthat after dispensing, opening of the cover member slides back thecarriage to its initial position.
 16. A device according to claim 15,wherein a pin on the cover member cooperates with a: cam track on thecarriage.
 17. A device according to any of claims 12 to 16, wherein thecarriage includes a surface which is blocked by the dispensing member inits first position, thus preventing movement of the carriage.
 18. Adevice according to claim 17, wherein the surface is at the end of anarm of the carriage.
 19. A device according to any of claims 12 to 18,wherein the carriage can be held in a forward position on the basemember by means of catch surfaces on the cover member.
 20. A deviceaccording to claim 10, claim 11 or to any of claims 12 to 19 whenappended to claim 10, wherein the latch has catches on the base memberwhich hold the actuating member, and wherein a push button on the baseor cover member is able to move the release member to cause inclinedsurfaces on the release member to move the catches to release theactuating member.
 21. A device according to claim 20, wherein thecatches are at the ends of resilient arms.
 22. A device according to anypreceding claim, wherein the dispensing member is nozzle shaped forinsertion in a nasal cavity.
 23. A device according to any of claims 12to 19, wherein the carriage and dispensing member are provided atopposite ends of the base member, the carriage being slidable in adirection towards the dispensing member in its second position, theactuating member comprising a piston rod arranged between the carriageand the dispensing member.
 24. A device according to claim 23 whenappendant on claim 11, wherein the latch has catches on the base memberwhich hold the actuating member, wherein a push button on the base orcover member is able to move the release member to cause inclinedsurfaces on the release member to move the catches to release theactuating member and wherein the release member is elongate and isarranged on the base member parallel to the piston rod, the safetycatches of the release member being at opposite ends thereof and thepush button being moveable perpendicularly to the release member.